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IRB Administrator
3 months ago
POSITION SUMMARY:
The IRB Administrator facilitates efficient and effective research compliance with institutional, state, and federal policies and regulations as they pertain to the conduct of human subjects research. The IRB Admin reviews human subject research submissions, performs complex IRB operations, and acts as a key resource for the research community on IRB issues.
ResponsibilitiesESSENTIAL FUNCTIONS:
IRB Administrator I:
Regulatory Review:
- Identify applicable regulations and policies for select IRB submissions, assessing for completeness and compliance.
- Interpret and apply applicable regulations and policies to select IRB submissions, exercising sound judgment in all assessments.
IRB Operations
- Manage operational requests (e.g., NCI CIRB reliance), evaluate supporting materials, and draft appropriate documentation and correspondence.
- Assist in design and execute tests of submission processes.
Education and Training:
- Collaborate with senior staff members to develop and implement IRB training materials and educational functions.
- Evaluate incoming IRB queries and respond or route appropriately.
- With appropriate supervision, advise research community on IRB matters.
Non-essential functions:
- Manage IRB events (room reservations, invitations/responses, etc.).
- Update IRB website, user accounts, etc.
IRB Administrator II:
Regulatory Review:
- Identify applicable regulations and policies for IRB submissions, assessing for completeness and compliance.
- Interpret and apply applicable regulations and policies to IRB submissions, exercising sound judgment in all assessments.
IRB Operations
- Manage operational requests (e.g., IRB reliance), evaluate supporting materials, and draft appropriate documentation and correspondence.
- Analyze and document processes and procedures.
- Assist in design and execute tests of submission processes.
Education and Training:
- Educate and advise research community on IRB matters.
IRB Admistrator III:
IRB Operations
- Oversee and direct the execution of individual investigator agreements, authorization agreements, and memorandums of understanding (MOUs) with external institutions or investigators.
- Design and execute tests of submission processes.
Education and Training:
- Contribute to development and implementation of IRB training materials and educational functions.
- Provide advice, guidance, and problem resolution to research community.
- Serve as subject matter expert on current and pending federal and state regulations as they apply to human subject research.
Program and Staff Management
- Provide team leadership for 1-3 employees.
- Coordinate and supervise training, evaluate and mentor team staff, review work products, and provide feedback regarding performance.
- Triage and assign new submissions.
- Perform other duties as required.
Sr IRB Admistrator:
Regulatory Review:
- Assist in preparing Institution for audits and deliberations with federal, state, and local agencies and organizations.
IRB Operations
- Maintain IRB committee membership in accordance with regulations, assuring breadth of experience, expertise, and diversity in accordance with the Institutional Assurance and orient new IRB members.
- In coordination with Committee Chairs, manage and coordinate Chair/Vice Chair reviewer schedules and work with Committee Chair to establish review consistency across full board and designated review activities.
Education and Training:
- Develop and implement IRB training materials and educational functions.
- Review new regulations and novel practices, analyze the impact for IRB workflows and campus community, and communicate relevant information to Board members, researchers, Program staff, and other relevant stakeholders.
Program and Staff Management
- Provide team leadership for 1-6 employees.
Qualifications
IRB ADMINISTRATOR I:
REQUIRED QUALIFICATIONS:
- Bachelor’s degree in a related field, or equivalent experience
- Minimum of 1year related experience
PREFERRED QUALIFICATIONS:
- Familiarity with research ethics and methods.
- Experience in human subjects research compliance.
- Relevant professional certification (e.g., CIP).
IRB ADMINISTRATOR II:
Requirements noted for IRB Admin I plus:
REQUIRED QUALIFICATIONS:
- Minimum of 2 to 4 years, including at least 1 year of experience in human subjects research compliance.
- Working knowledge of human subjects regulations (e.g., DHHS, FDA) and guidance applicable to human subject research studies.
PREFERRED QUALIFICATIONS:
- Master’s degree
- Familiarity with software programs developed for research administration or web-based submissions and tracking.
IRB ADMINISTRATOR III:
Requirements noted for IRB Admin I plus:
REQUIRED QUALIFICATIONS:
- Minimum of 5-7 years of experience in administration, management, and policy, preferably within an academic institution, hospital, or government IRB including at least 2 years of experience in human subjects research compliance.
- Familiarity with AAHRPP standards and requirements.
- Relevant professional certification (e.g., CIP); Willingness to obtain certification within a reasonable timeframe (6 to 12 months) as a certified IRB professional (CIP) upon meeting the eligibility requirements and to maintain certification through continuing education and re-certification for the duration of employment.
Sr IRB ADMINISTRATOR:
Requirements noted for IRB Admin I plus:
REQUIRED QUALIFICATIONS:
- Minimum of 7 years of experience in administration, management, and policy, preferably within an academic institution, hospital, or government IRB including at least 3 years of experience in human subjects research compliance.
- Extensive knowledge of human subjects regulations (e.g., DHHS, FDA) and guidance applicable to human subject research studies.
- At least 1 year of experience training or mentoring staff.
** This is a hybrid work model with the understanding that the IRB Administrator I/II/III or Sr IRB Administrator will be available and onsite as required to support the department. **
